Clinical Evaluation Experts - Dunes Medical Writing’s Post

A new HHS-OIG audit found that CDC and SAMHSA used an iterative process to collect and report performance data on reducing overdose deaths. The agencies faced challenges in reporting data on time to the Office of National Drug Control Policy (ONDCP) and in providing final data to meet ONDCP's reporting deadline. Read more: https://direc.to/fj_F

Which are valid adverse event reports? 💡 ✏️ The minimum dataset required to consider information as a reportable AE is indeed minimal, namely (1) an identifiable patient, (2) an identifiable reporter, (3) product exposure, and (4) an event. However, in addition to direct data collection, AEs can be detected through retrospective analysis of a population database, where direct patient or health care provider contact does not occur. Patient interactions include clinical interactions and data collection by phone, Internet, or other means; perusal of electronic medical records or insurance claims data would not be considered direct patient interaction. Reporting is rarely required for individual AEs observed in aggregate population data, since there is no direct patient interaction where an association might be suggested or inferred. Nevertheless, if aggregate or epidemiologic analyses suggest that an AE is associated with exposure to a drug or medical product, it is desirable that the minimum dataset information be forwarded to the manufacturer of the product, who will determine any need for, and timing of, reporting of study results to the relevant regulatory authorities.

#Savethedate The FDA is hosting a #LDT-related #webinar this Thursday, August 22 with focus on #MedicalDeviceReporting. Registration is not necessary. Read more: https://lnkd.in/gAqCgyr7 Link to join the webinar: https://lnkd.in/dyi7n4v3 Link Disclaimer Passcode: %KeTf9 #invitrodiagnostics #diagnostics #fdacompliance #complaintreporting

🌐 FDA's New Rule for Laboratory Developed Tests (LDTs): What It Means 🌐The FDA's final rule on LDTs is a big shift in diagnostic regulation, aiming to enhance public health by ensuring test quality and reliability. On December 3, join an FDA-hosted webinar to gain insights into new compliance requirements, phased timelines, and enforcement policies affecting labs, providers, and patients. 🗓 Date: December 3 🔗https://lnkd.in/gb9ZQSxD #LDTs #FDARegulations #IVD #Diagnostics

What does a KRI Stands for in clinical trials?🤔 In clinical trials, KRI stands for Key Risk Indicator. KRIs are metrics used to identify and monitor potential risks that could impact the success or integrity of the trial. These indicators help in proactively managing and mitigating risks to ensure the trial is conducted according to protocol, regulatory requirements, and Good Clinical Practice (GCP) standards. Key Risk Indicators typically include: 1. Protocol Deviations. 2. Patient Enrollment. 3. Data Quality. 4. Adverse Events. 5. Site Performance By regularly analyzing these KRIs, sponsors and investigators can identify potential issues early, implement corrective actions, and ensure the trial's success and integrity. #clinicaltrials #KRI #Keyriskindicator #CAPA #clinicalresearch

Hear from Dr. Asma Patel, VP of Integrated Development Services, in this #blog focused on #CMC challenges often faced when developing life-saving treatments and discover more about strategies to mitigate CMC risks. Read here: https://bit.ly/3LYwFmU

Reasonable Cause drug screening can indeed be challenging, and if not conducted properly, the consequences can be significant. However, it doesn’t have to be complicated. By the end of our two-hour session, you'll be feeling as confident as the group pictured below, equipped with the knowledge of what to look for and how to appropriately obtain the donor's consent. #drugScreening #ReasonableCauseTesting #advanceDiagnostics #ProactiveLeaders #HealthandSafety

An adverse drug event or #ADE is the catch-all term used to describe medication-related harm, including harm coming from appropriate use of the medication(s). Tools and technologies, like MedWise, are available to help identify which medication, and which dose, is right for each patient—before an #ADE occurs. 👉Learn more: https://loom.ly/9QkPmqE #FourthCause #MedicationSafety #ADEAwareness

Do you anticipate the Food and Drug Administration’s (FDA) laboratory-developed test final rule creating unnecessary burdens for pathologists or negatively impacting patients’ lives, innovation, or the economy on your community? Your story could be used to help legislators understand how the oversight of tests should be based on protecting patients and providing access to safe diagnostic tests with a framework that is the least burdensome for laboratories. Click on the link below, fill out the form, and tell us more. https://brnw.ch/21wL5mi

Do you anticipate the Food and Drug Administration’s (FDA) laboratory-developed test final rule creating unnecessary burdens for pathologists or negatively impacting patients’ lives, innovation, or the economy on your community? Your story could be used to help legislators understand how the oversight of tests should be based on protecting patients and providing access to safe diagnostic tests with a framework that is the least burdensome for laboratories. Click on the link below, fill out the form, and tell us more. https://brnw.ch/21wL5mi